OPTICROSS 8655

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-02-11 for OPTICROSS 8655 manufactured by Boston Scientific Corporation.

Event Text Entries

[179492109] Device evaluated by mfr: device analysis revealed that the device had a detachment in the lapjoint section. The device had the imaging window detached and the imaging window did not return with the device. Additionally, kink was observed in the imaging core and sheath assembly, hence, the reported complaint of "failure to advance" was confirmed due the kink found. The reported complaint of "lost image" was not confirmed due the condition of the device. Even so, it is important to mention that a impedance inspection was performed and the device showed a good curve line, furthermore, the transducer appears to be in good condition.
Patient Sequence No: 1, Text Type: N, H10


[179492110] Reportable based on device analysis completed on 17jan2020. It was reported that the device was unable to cross the lesion. The target lesion was located in the severely tortuous and moderately calcified right coronary artery. The opticross catheter was advanced but was unable to cross the lesion. Pullback was performed, but the image immediately disappeared. The procedure was competed with a different device. No patient complications were reported. However, device analysis revealed a detached imaging window from the lap joint.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-01339
MDR Report Key9695662
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-02-11
Date of Report2020-02-11
Date of Event2019-12-04
Date Mfgr Received2020-01-17
Device Manufacturer Date2019-08-22
Date Added to Maude2020-02-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJAY JOHNSON
Manufacturer StreetTWO SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal55311
Manufacturer Phone7634942574
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer Street2546 CALLE PRIMERA
Manufacturer CityALAJUELA
Manufacturer CountryCS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOPTICROSS
Generic NameCATHETER, ULTRASOUND, INTRAVASCULAR
Product CodeOBJ
Date Received2020-02-11
Returned To Mfg2019-12-20
Model Number8655
Catalog Number8655
Lot Number0024307580
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressTWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-11

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